NCT07362212

Brief Summary

Objective assessment of mobility, balance, and lower extremity function in older adults is of great importance in both clinical practice and scientific research. For this purpose, performance-based tests that can be administered in a short time, are easily repeatable, and have high clinical practicality are widely preferred. These tests provide valuable information about older adults' ability to perform activities of daily living, levels of functional independence, and risk of falls, thereby contributing significantly to both diagnostic processes and treatment planning. One of these tests, the 4-Meter Walk Test (4MWT), is among the simplest and most reliable methods used to assess walking speed in older adults. Gait speed is considered a strong indicator of functional capacity and overall health status in older individuals and is also used as a critical parameter for predicting mortality, morbidity, hospitalization rates, and duration of independent living. Therefore, due to its short administration time, high repeatability, and clinical validity, the 4MWT has become one of the standard assessment tools in the field of geriatrics. Another frequently used assessment tool, the Five-Times Sit-to-Stand Test (5xSTS), is based on measuring the time required for an individual to consecutively stand up from and sit down on a chair five times. This test is closely associated with lower extremity muscle strength, functional independence, and the ability to maintain activities of daily living. In addition, the 5xSTS test is an important clinical tool for identifying muscle weakness and mobility limitations in older adults with a history of falls. Owing to its short administration time, lack of requirement for specialized equipment, and ease of understanding, it is widely used in both clinical settings and field studies. In addition, the Timed Up and Go (TUG) test is considered one of the gold standard methods for the assessment of functional mobility. The test is simple to administer: the time required for an individual to stand up from a chair, walk a specified distance, turn around, and return to sit down is measured. The TUG test not only assesses mobility but is also a reliable and valid method for predicting balance impairments and fall risk. Given that falls represent a major health concern in older adults, data obtained from the TUG test provide valuable guidance for both clinicians and researchers. In recent years, virtual reality (VR)-based assessment methods have attracted increasing attention due to their potential to provide a safe, motivating, and standardized environment, particularly for older adults. In this study, the Meta Quest 3 virtual reality headset and controllers will be used to implement VR-based functional tests. The Meta Quest 3 device features a resolution of 2064 × 2208 pixels per eye, a maximum refresh rate of 120 Hz, and a six-degrees-of-freedom (6 DoF) inside-out tracking system. The device tracks participants' head and body movements in real time and accurately reflects them within the virtual environment. This system does not require external sensors and automatically provides positional tracking in the virtual space. Previous studies have demonstrated that VR applications can produce valid and reliable outcomes when used as digital adaptations of functional tests. However, the validity and reliability of VR adaptations of the 4MWT, 5xSTS, and TUG tests in older adults have not yet been systematically investigated. The rationale of this study is to determine whether VR-based short performance tests can serve as a safer, more easily repeatable, and potentially more accessible alternative to conventional clinical assessments. The findings of this study are expected to provide important evidence supporting the use of VR technology in clinical practice for the assessment of mobility and balance in older adults.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Jul 2026

First Submitted

Initial submission to the registry

January 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Last Updated

January 23, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 15, 2026

Last Update Submit

January 15, 2026

Conditions

Keywords

Older AdultsFunctional MobilityVirtual Reality4-Meter Walk TestFive-Times Sit-to-Stand TestTimed Up and Go TestValidity and Reliability

Outcome Measures

Primary Outcomes (3)

  • 4-Meter Walk Test - Virtual Reality (4MWT-VR)

    This outcome measure will be used to assess gait speed using a virtual reality-based adaptation of the 4-Meter Walk Test. Walking speed will be automatically calculated by the system. Validity will be evaluated by comparison with the conventional 4-Meter Walk Test, and reliability will be assessed using repeated measurements performed 5-7 days apart.

    Baseline and 5-7 days

  • Five-Times Sit-to-Stand Test - Virtual Reality (5xSTS-VR)

    This outcome measure will be used to assess lower extremity functional performance using a virtual reality-based adaptation of the Five-Times Sit-to-Stand Test. Test duration will be automatically recorded. Validity and reliability will be evaluated by comparison with the conventional test and repeated measurements.

    Baseline and 5-7 days

  • Timed Up and Go Test - Virtual Reality (TUG-VR)

    This outcome measure will be used to assess functional mobility using a virtual reality-based adaptation of the Timed Up and Go test. Test completion time will be automatically recorded by the system. Validity and reliability will be examined through comparison with the conventional Timed Up and Go test and repeated measurements.

    Baseline and 5-7 days

Secondary Outcomes (5)

  • 4-Meter Walk Test - Conventional

    Baseline

  • Five-Times Sit-to-Stand Test - Conventional

    Baseline

  • Timed Up and Go Test - Conventional

    Baseline

  • Lower Extremity Muscle Strength

    Baseline

  • Physical Activity Level (International Physical Activity Questionnaire - Short Form, IPAQ-SF)

    Baseline

Study Arms (1)

Older Adults

Older adults undergoing conventional and virtual reality-based assessments of functional mobility, balance, and lower extremity function, including the 4-Meter Walk Test, Five-Times Sit-to-Stand Test, and Timed Up and Go Test, to evaluate validity, reliability, and clinical correlates.

Other: Clinical Assessments

Interventions

Participants will perform virtual reality-based adaptations of the 4-Meter Walk Test, Five-Times Sit-to-Stand Test, and Timed Up and Go Test using an immersive virtual reality application developed for the Meta Quest 3 platform. The virtual environment digitally replicates the conventional test setups and protocols, and performance outcomes are automatically recorded by the system. Virtual reality-based assessments will be compared with conventional clinical tests and repeated to evaluate validity, reliability, and clinical correlates.

Older Adults

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community-dwelling adults aged 65 years and older who are able to ambulate independently (with or without assistive devices) and can communicate and follow test instructions.

You may qualify if:

  • Aged 65 years or older,
  • Ability to ambulate independently (assistive devices permitted),
  • Cognitive ability sufficient to communicate and follow instructions,
  • Provision of written informed consent.

You may not qualify if:

  • Acute cardiopulmonary disease,
  • Uncontrolled hypertension,
  • History of lower extremity surgery or fracture within the past 6 months,
  • Severe cognitive impairment preventing cooperation with testing procedures,
  • Determination by a healthcare professional that participation is unsafe for safety-related reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Konya, Selcuklu, 42130, Turkey (Türkiye)

Location

Related Publications (5)

  • Saglam M, Arikan H, Savci S, Inal-Ince D, Bosnak-Guclu M, Karabulut E, Tokgozoglu L. International physical activity questionnaire: reliability and validity of the Turkish version. Percept Mot Skills. 2010 Aug;111(1):278-84. doi: 10.2466/06.08.PMS.111.4.278-284.

    PMID: 21058606BACKGROUND
  • Maden C, Gozacan Karabulut D, Bagci B. Validity and reliability of an immersive virtual reality adaptation of the 6-minute pegboard and ring test. Hand Surg Rehabil. 2025 Feb;44(1):101981. doi: 10.1016/j.hansur.2024.101981. Epub 2024 Oct 30.

    PMID: 39486588BACKGROUND
  • Barry E, Galvin R, Keogh C, Horgan F, Fahey T. Is the Timed Up and Go test a useful predictor of risk of falls in community dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2014 Feb 1;14:14. doi: 10.1186/1471-2318-14-14.

    PMID: 24484314BACKGROUND
  • Bohannon RW. Sit-to-stand test for measuring performance of lower extremity muscles. Percept Mot Skills. 1995 Feb;80(1):163-6. doi: 10.2466/pms.1995.80.1.163.

    PMID: 7624188BACKGROUND
  • Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

    PMID: 21205966BACKGROUND

Study Officials

  • İsmail ÖZSOY, Assoc. Prof. Dr.

    Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

    STUDY CHAIR
  • Gülşah ÖZSOY, Assist. Prof. Dr.

    Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

    STUDY CHAIR
  • Zehra KORKUT, Assist. Prof. Dr.

    Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

    STUDY CHAIR
  • Mehmet A GÜLER, PhD

    Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

    STUDY CHAIR
  • Yasemin GEDİKLİ ERTÜRK, MSc. in PT

    Selcuk University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Konya, Türkiye

    STUDY CHAIR
  • Muhammed İ KODAK, Assist. Prof. Dr.

    Kırşehir Ahi Evran University, School of Physical Therapy and Rehabilitation, Kırşehir, Türkiye

    STUDY CHAIR
  • Ahmet ÇİZMECİOĞLU, Assoc. Prof. Dr.

    Selcuk University, Faculty of Medicine, Department of Internal Medicine, Konya, Türkiye

    STUDY CHAIR

Central Study Contacts

Mehmet K ALTUNOK, PHD(c) in PT

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 15, 2026

First Posted

January 23, 2026

Study Start

February 2, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Last Updated

January 23, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations